辨证论治失眠疗效评价医生队列研究

Cohort Study of Evaluating the Outcomes of Insomnia Treated by TCM Patterns Differentiation Among Different TCM Physicians

目的:以失眠为例,评价医生辨证论治失眠的效果,分析不同医生的疗效差异及疗效特点;探索应用医生队列研究构建辨证论治疗效评价的基本方法。方法:纳入合格患者,4名医生根据患者的具体情况决定患者治疗方法、就诊时间和治疗疗程,地点为日常门诊。选择临床医生公认的PSQI和TST治疗前后有效率作为判效标准比较和评价医生间辨证论治疗效。其次,通过数据挖掘的方法整理每个医生证-治-效的关系和内容。最后,通过数据挖掘结果补充不同医生的证治效内容并比较不同医生间证治效内容的异同。结果:四名医生在TST和PSQI两个主要疗效评价指标上,疗效从高到低的排序是医生C、医生D、医生B、医生A。影响辨证论治失眠疗效主要因素是与疾病相关的症状。数据挖掘结果以医生A为例,在专家文本方的基础上分析得到3个核心类方,通过挖掘类方得到核心方药,对应人群特点和疗效变化特点。医生A个体辨证论治的证治效相关性强于医生间证治效相关性,医生个体证治效关系的紧密程度较高,医生之间证治效关系存在差异;结果说明辨证论治是以医生为核心,证治效紧密相关的个体化诊疗过程。而且结果证明队列试验的设计和实施、数据挖掘和分析等方法是科学且可行的。结论:以医生为核心的队列研究方法可以评价辨证论治的效果,分析医生辨证论治的规律和特点;体现以医生为核心,证-治-效紧密相关、动态的、个体化与整体调节的辨证论治结局的评价是科学且可行。

Objective：Take insomnia as an example, to evaluate the effect of physicians＇ treatment for insomnia by TCM patterns differentiation, and to analyze the difference and the characteristics of TCMphysicians＇ treatment. Based on the results of former two, the methodology was explored and established to evaluate the effect of treatment by the TCM patterns differentiation with the application of physicians＇ cohort study. Methods ： The participants were included if they complained insomnia as chief complaint, met the diagnosis of insomnia disorders. The TCM physicians treat patients according to the patient individualized health condition at their outpatient clinics. Main outcomes selected by experts were effective rates of PSQ] and TST. Data mining was applied for the comparison of the contents of TCM patterns, treatment and outcomes, which also helped to compliment the content of TCM patterns, treatment and outcomes of individual TCM physician. Results ： The outcome effective rates of TST and PSQI from high to low ranks were TCM Physician C, D, B, A. That meant the insomnia related symptoms were the main factors influencing the effective rates. Results of data mining took TCM physician A as an example that three core prescriptions were analyzed based on those that the TCM physician offered. TCM patterns, individualized treatment and changes of outcomes were obtained. Besides, the qualitative comparisons were conduct between the results of data mining and those the TCM physician offered. The correlation of TCM patterns, individualized treatment and changes of outcomes from TCM physician A was stronger than those from either two TCM physicians, which proved that the TCM physician A showed high self-consistence in the relationship of TCM patterns, individualized treatment and changes of outcomes ; but there were large differences between either two TCM physicians. The results proved the research hypothesis that TCM patterns differentiation took TCM physicians as the core part, and was an individualized diagnosis and treatment process of high correlation of TCM patterns, individualized treatment and changes of outcomes. All above results could prove that the methodology of cohort study design, complement, data mining and analyses was scientific and feasible. Conclusion：TCM physicians as the core of the cohort study method can evaluate the effect of different physicians＇ treatment based on their TCM patterns differentiation. Based on the effectiveness of the TCM physicians＇ treatment, the regularity and characteristics of their treatment by TCM patterns differentiation were analyzed. That method was scientific and feasible to the research hypothesis that TCM patterns differentiation took TCM physicians as the core part, and was an individualized diagnosis and treatment process of high correlation of TCM patterns, individualized treatment and changes of outcomes.